Cleven
Generic Name
Enoxaparin Sodium (4000 anti-Xa IU)
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| cleven 4000 anti xa injection | ৳ 450.00 | N/A |
Description
Overview of the medicine
Cleven 4000 anti-Xa Injection contains Enoxaparin Sodium, a low molecular weight heparin (LMWH). It is used to prevent and treat blood clots in various medical conditions.
Uses & Indications
Dosage
Adults
Dosage varies by indication: For DVT prophylaxis, typically 40 mg (4000 anti-Xa IU) subcutaneously once daily. For DVT treatment, 1 mg/kg subcutaneously every 12 hours or 1.5 mg/kg subcutaneously once daily.
Elderly
No general dose adjustment is needed based on age alone, but renal function should be monitored, as elimination is primarily renal.
Renal_impairment
Dose adjustment is necessary in patients with severe renal impairment (creatinine clearance <30 mL/min). For DVT prophylaxis, 20 mg (2000 anti-Xa IU) subcutaneously once daily.
How to Take
Administer by deep subcutaneous injection. Do not administer intramuscularly. For hemodialysis, it is administered into the arterial line of the dialyzer at the beginning of dialysis. Do not mix with other injections or infusions.
Mechanism of Action
Enoxaparin works by potentiating the action of antithrombin III, which leads to the inactivation of Factor Xa and, to a lesser extent, Factor IIa (thrombin). This prevents the formation and growth of blood clots.
Pharmacokinetics
Onset
Peak anti-Xa activity achieved within 3-5 hours after subcutaneous administration.
Excretion
Mainly excreted by the kidneys (approximately 40% of the dose is eliminated via the renal route as active and inactive fragments).
Half life
The elimination half-life of anti-Xa activity is approximately 4.5-7 hours after a single subcutaneous dose.
Absorption
High (approximately 100%) bioavailability after subcutaneous injection.
Metabolism
Primarily metabolized in the liver by desulfation and depolymerization into less active or inactive metabolites.
Side Effects
Contraindications
- Active major bleeding or conditions with a high risk of uncontrolled hemorrhage.
- History of heparin-induced thrombocytopenia (HIT) with or without thrombosis.
- Hypersensitivity to enoxaparin sodium, heparin, or any other components of the product.
Drug Interactions
Oral anticoagulants (e.g., warfarin)
Concurrent use requires careful monitoring and bridging therapy.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
Increased risk of bleeding.
Antiplatelet agents (e.g., aspirin, clopidogrel)
Increased risk of bleeding.
Other anticoagulants (e.g., unfractionated heparin, dabigatran)
Increased risk of bleeding.
Storage
Store below 30°C. Do not freeze. Protect from light. Keep out of reach of children.
Overdose
Overdose can lead to hemorrhagic complications. The anticoagulant effects can be largely neutralized by the slow intravenous injection of protamine sulfate.
Pregnancy & Lactation
Enoxaparin is generally considered safe for use during pregnancy when indicated, although specific guidance should come from a healthcare provider. It is excreted into breast milk in very small amounts, and significant absorption by the infant is unlikely. Consult a doctor before use during pregnancy or lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture. Check the expiry date on the packaging.
Availability
Pharmacies, Hospitals
Approval Status
Approved (Generic Enoxaparin)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Enoxaparin has been extensively studied in numerous clinical trials demonstrating its efficacy and safety in various indications, including DVT prophylaxis and treatment, and management of acute coronary syndromes.
Lab Monitoring
- Complete Blood Count (CBC) with platelet count (before and during therapy)
- Renal function (creatinine clearance) in all patients, especially elderly and those with renal impairment.
- Anti-Xa levels (may be considered in obese, pregnant, or renally impaired patients, or in cases of suspected overdose).
Doctor Notes
- Assess bleeding risk factors before initiating therapy and throughout treatment.
- Monitor platelet counts for potential heparin-induced thrombocytopenia.
- Dose adjust for severe renal impairment. Exercise extreme caution when administering to patients undergoing neuraxial anesthesia or spinal puncture due to the risk of spinal/epidural hematoma.
Patient Guidelines
- Follow proper subcutaneous injection technique as instructed by your healthcare provider.
- Report any signs of unusual bleeding or bruising immediately to your doctor.
- Inform all healthcare providers (including dentists) that you are taking this medication.
- Avoid taking over-the-counter NSAIDs, aspirin, or other blood thinners without consulting your doctor.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Enoxaparin is not known to affect the ability to drive or operate machinery.
Lifestyle Advice
- Avoid activities that may increase your risk of bleeding or injury.
- Maintain good hydration.
- Adhere to regular follow-up appointments for monitoring.
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